Inspector General says FDA Did Not Follow Procedure with 2007 Pet Food Recall

A newly released report from the Office of Inspector General has some harsh words to report about the FDA’s handling of the 2007 pet food recall.

At last, the Office of Inspector General reports that the FDA needs some improvement when it comes to pet food. “FDA has developed procedures for monitoring recalls and assessing a firm’s recall effectiveness. However, FDA did not always follow its procedures in overseeing three of the five recalls that we reviewed. Furthermore, FDA’s procedures were not always adequate for monitoring large recalls. FDA’s lack of authority, coupled with its sometimes lax adherence to its recall guidance and internal procedures and the inadequacy of some of those procedures, limited FDA’s ability to ensure that contaminated pet food was promptly removed from retailers’ shelves.” http://oig.hhs.gov/oas/reports/region1/10701503.asp

Those are some strong words! (Thank you!) The Office of Inspector General reported the FDA’s ‘lax adherence’ to protocol limited the removal of deadly pet food from store shelves. I interpret this statement to mean the FDA is in part responsible for pet deaths. Had the FDA followed their own procedures, deadly contaminated pet food would have been promptly removed from retailers’ shelves and perhaps thousands of lives would have been saved.

“Contrary to its procedures, however, FDA did not ensure that Menu Foods’ recall strategy included the FDA-assigned depth and level of effectiveness checks that Menu Foods would conduct. In addition, FDA did not promptly send Menu Foods a notification letter specifying the level of the effectiveness checks. According to FDA, it confirmed its understood that Menu Foods would conduct effectiveness checks in a March 23, 2007, email to Menu Foods. However this email did not specify that FDA expected Menu Foods to conduct effectiveness checks of 100 percent of its distributors and retailers. FDA did not send Menu Foods a notification letter containing this information until September 21, 2007, 6 months after the recalls began.”

“Adequacy of Procedures”
“FDA’s inspection procedures did not ensure that FDA verified the accuracy and completeness of Menu Foods’ recall list. Specifically, FDA’s procedures did not require that FDA promptly reconcile the firm’s production records to its raw material lists to ensure that the recall list covered all contaminated lots.”

“Because FDA did not perform a detailed reconciliation of Menu Foods’ production records and raw material lists at the time of the March 2007 inspection, FDA was unaware that the production records did not document the transfer of 11,000 pounds of contaminated wheat gluten to a Canadian plant before the recalls began. FDA remained unaware of the transferred wheat gluten until April 9, 2007, when FDA learned that the University of California at Davis had traced the death of a pet to a brand of Menu Foods pet food that was not on the recall list. On April 11, 2007, FDA began an in depth reconciliation of Menu Foods’ records and confirmed that the Canadian plant had produced melamine-contaminated pet food that was not on the recall list.”

“Although Menu Foods was responsible for providing FDA with accurate and complete records, a timely reconciliation of Menu Foods’ records would have helped FDA determine that the records provided were not complete and that not all contaminated pet food lots had been recalled.”

“Adherence to Procedures”
During the first round, FDA did not always adhere to its procedures when conducting audit checks at the 64 retail stores:
• Of the 64 store visit forms, 40 were missing one or more pieces of required information, such as the amount of product that the store had removed from its shelves and the amount still remaining on its shelves.
• FDA did not tabulate the results of the 64 store visits and therefore could not adequately assess the effectiveness of the recall effort as required. Our tabulation of the first round of audit checks, based on the information available on the store visit forms, indicated that 20 percent of the stores visited still had recalled products on their shelves.”

“In addition, some of the 1,195 store visit forms that inspectors submitted did not contain all requested information or contained misclassified results. For example, the store visit forms for 31 stores classified the recalls as effective even though the stores (1) had not received notice of the recalls or (2) said that they had received notice of the recalls but had not removed the products from their shelves.”

“A retail store that was first notified of the recall on March 18, 2007, still had 185 cans of recalled pet food on its shelves when FDA conducted its audit check on April 16, almost a month after the store was notified.”

“A retail store that was part of a large national chain had 470 pouches and cans of recalled pet food on its shelves when, as part of the blitz, the District of Columbia’s health agency conducted an audit check on April 13, 2007, almost 4 weeks after the recalls began.”

“According to FDA officials, FDA had specified during recall strategy discussions that Menu Foods should conduct effectiveness checks at 100 percent of its affected distributors and retailers, which FDA estimated to total more than 10,000. Thus, Menu Foods conducted effectiveness checks at fewer than 30 percent of its distributors and retailers. We found no evidence that FDA had followed up with Menu Foods to determine why the firm had not promptly initiated and completed the specified level of effectiveness checks.”

Now that this report has been provided to Congress, I guess we’ll see if Congress bothers to do anything about it. By the way, the following is also an excerpt from the Inspector General Report…
“Government Accountability Office Report
An October 2004 Government Accountability Office (GAO) report identified weaknesses in the U.S. Department of Agriculture’s (USDA) and FDA’s food recall programs. The report stated: “We believe that addressing the problems we have identified could raise the likelihood that recalled food will be removed from the marketplace more promptly and completely. However, these corrective steps, while necessary, will still leave fundamental vulnerabilities because the agencies lack specific recall authority available to other agencies with consumer safety responsibilities.” The report recommended that Congress consider legislation that would give USDA and FDA the authority to issue mandatory recalls, to establish recall requirements, and to impose monetary penalties or seek fines or imprisonment for firms that do not follow food recall requirements.”

Yet Congress has STILL NOT provided the FDA with authority to issue mandatory recalls.

What is it going to take? How many pets and people have to die before someone in Congress takes the initiative to fix the FDA?